Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

15876–15900 of 40287

HighFDA (Devices)·Z-0478-2021·2020-12-02
RayStation software recall for potential incorrect treatment plan references
RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.
Product
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0485-2021·2020-12-02
Mevion Proton Radiation Treatment System Recalled for Screen Display Failure
Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.
Product
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2021·2020-12-02
Intuitive Surgical Recalls ION Fully Articulating Catheters Due to Tip Ring Risk
Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.
Product
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2021·2020-12-02
ViewRay MRIdian System Recalled for Potential Burn Injury Risk
ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.
Product
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2021·2020-12-02
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects
Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0496-2021·2020-12-02
Medtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects
Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0479-2021·2020-12-02
Encore Medical Recalls EMPOWR Partial Knee Peg Drill Guide
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.
Product
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0494-2021·2020-12-02
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0477-2021·2020-12-02
Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.
Product
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0480-2021·2020-12-02
Encore Medical Recalls EMPOWR Partial Knee Peg Drill Due to Binding
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill because the shaft may bind within the guide, potentially delaying surgery.
Product
EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0486-2021·2020-12-02
Advanced Bionics Recalls Mislabelled PowerCel 230 Cochlear Implant Batteries
Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.
Product
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0495-2021·2020-12-02
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
Medtronic is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0476-2021·2020-12-02
Luminex Recalls Verigene Processor SP Due to Unapproved Service Fixtures
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify the devices.
Product
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0487-2021·2020-12-02
Advanced Bionics Recalls 28 Mislabelled Cochlear Implant Batteries
Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.
Product
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2021·2020-11-25
Cardinal Health Recalls Kangaroo Connect 500ml Bag Sets Due to Leakage
Cardinal Health is recalling Kangaroo Connect 500ml Bag Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2021·2020-11-25
Stryker Recalls Osteosynthesis Compression Staple EasyClip Devices
Stryker GmbH is recalling EasyClip and EasyClip Xpress staples due to potential nickel release above safety margins in pediatric patients under 20 kg.
Product
Osteosynthesis Compression Staple EasyClip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2021·2020-11-25
MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk
Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.
Product
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0449-2021·2020-11-25
Thomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes
Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes to replace units manufactured and distributed prior to Enforcement Discretion Approval.
Product
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2021·2020-11-25
Mako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies
Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.
Product
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2021·2020-11-25
Cardinal Health Recalls Kangaroo Connect 1000ml Bag Sets Due to Leak Risk
Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets because the feeding spike sets may leak at the tube and spike connector interface.
Product
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0442-2021·2020-11-25
GE v|tome|x L Series X-ray Systems Recalled for Warning Signal Defect
GE Inspection Technologies is recalling v|tome|x L Series X-ray systems because pre-warning signals may fail to activate if the warm-up mode is not completed.
Product
v|tome|x L Series non-destructive testing cabinet x-ray systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0455-2021·2020-11-25
Merit Medical Cultura Collection and Transport System recall due to swab tip breakage risk
Merit Medical recalls its Cultura Collection and Transport System because the swab tip may break off during sample collection, potentially causing soft tissue injury.
Product
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2021·2020-11-25
Roche Recalls cobas infinity Software Due to Incorrect Validation
Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.
Product
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0456-2021·2020-11-25
Merit Medical Cultura Collection and Transport System Swab Tip Breakage Recall
Merit Medical is recalling Cultura Collection and Transport Systems because the swab tip may break off during sample collection, potentially causing soft tissue injury.
Product
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2021·2020-11-25
Medicrea Ligapass Tension Pulley Handle Recalled for Band Breakage Risk
Medicrea International is recalling Ligapass Tension Pulley Handles because the instrument can crush the band, causing it to break during surgery and leading to infection risk.
Product
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Category
Medical Device
Distribution
1 state

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15876–15900 of 40287